NCT01835613UnknownPhase 4
Evaluation Effects of Treatment With IL-6R Inhibitor on Clinical Response and Biomarkers in Patients With Rheumatoid Arthritis (RA) Not Responding to DMARDs and/or a First Biological Agent.
Osservatorio Epidemiologico GISEA1 site in 1 country150 target enrollmentStarted: January 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Disease Activity Score (DAS-44)
Study Overview
Brief Summary
The purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed informed consent form;
- •Patients aged 18 - 75 years;
- •RA classified in compliance with the 2010 ACR/EULAR criteria;
- •Patients that have to suspend a previous treatment with DMARDs for total ineffectiveness or intolerance to drugs and/or patients that have not responded adequately to first-line combination DMARDs / biological treatment;
- •Patients for which is indicated to start a treatment with an inhibitor of IL-6R for high values indicative of systemic inflammation (ESR>=28 mm/hour, PCR>5 mg/l , Fibrinogen >400 mg/dl and or Albumin <3.5 g/dl) and high disease activity (DAS>2.4), or contraindications to DMARDs use which make it necessary to take biological drug in monotherapy.
- •Corticosteroids therapy stable (< = 7.5 mg)for at least four weeks;
- •Joint symptoms for at least three but no more than 24 months from the screening visit;
- •DAS44 >2.4 and/or SDAI >11
- •Willing and able to comply with study procedures and timing.
Exclusion Criteria
- •On going pregnancy or lactation;
- •Severe active infections;
- •Patients with other clinically significant concomitant diseases whose treatment or outcome could interfere with the expected evaluations of the study protocol.
- •Blood AST or ALT levels >5 times the upper normal limit;
- •ANC count <0.5 x 109/L
- •Platelet count <50 x103 /μL
- •Patients with other autoimmune rheumatic diseases, in addition to AR (for example systemic lupus erythematosus [SLE], scleroderma, polymyositis, ecc...)
- •Medical history or concomitant joint diseases in additions to AR (for example tophaceous gout, reactive arthritis, psoriatic arthritis).
Outcomes
Primary Outcomes
Disease Activity Score (DAS-44)
Time Frame: 12 months
Secondary Outcomes
- Simplified Disease Activity Index (SDAI);Biomarkers Measures(SDAI at 3-6-12-18 months)
- Biomarkers Measures(Biomarkers Measures at 3-6-12-18 months)
Investigators
Study Sites (1)
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